Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Pa… (NCT06519591) | Clinical Trial Compass
RecruitingPhase 2
Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis
China40 participantsStarted 2025-02-25
Plain-language summary
In this phase 2 study, we combined Cadonilimab, LM-302, and S-1 combined with intraperitoneal infusion of paclitaxel as regimen to treat gastric cancer patients with peritoneal metastasis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed gastric adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
✓. Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction; Written (signed) informed consent;
✓. Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%);
✓. Age ≥ 18 years at registration;
✓. Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
✓. Expected life expectancy \> 3 months;
✓. Adequate bone marrow, liver, and renal functions.
Exclusion criteria
✕. Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);
✕. During pregnancy, within 28 days of post parturition, or during lactation;
✕. Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4 or targeted therapy such as Claudin 18.2.
✕. Synchronous or metachronous (within 5 years) malignancies.
✕. Severe mental disease, uncontrolled epilepsy, or central nervous system disease;
✕. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months;
✕. Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome may affect S-1 absorbers;
✕. Known peripheral neuropathy (\> NCI-CTC AE 1). However, patients with only disappearance of deep tendon reflex (DTR) need not be excluded;